Apparatuses and methods for injecting medicaments

ABSTRACT

The disclosure relates to injectors that are configured to inject and deliver medicaments and other fluids from a syringe into a target site.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 17/212,226, filed Mar. 25, 2021, which claims thebenefit of priority to U.S. Provisional Patent Application No.62/994,448, filed on Mar. 25, 2020, the entire disclosure of each ofwhich is expressly incorporated herein by reference in its entirety.

FIELD

The invention relates to injectors for medicaments and other fluids.Specifically, to injectors configured to inject a medicament and otherfluids from a syringe.

BACKGROUND

Many methods are used to inject medicaments and other fluids into atarget site. These include syringes, auto-injectors, and drug pumps. Themedicament can be injected at a variety of depths. For example, themedicament can be injected into the epidermis, the dermis, thesubcutaneous region, or into the muscles (intramuscular). Medicament orother fluids can also be delivered intravenously, intraosseusly, and/orto other parts of the body such as into the eye. Some of these devicesare specifically intended for at home use by a patient. These devicescan be used to deliver a variety of medicaments. For example, theinjectors can be used for the delivery of epinephrine to patients whoare at risk of anaphylaxis. Such devices include the ANAPEN™ injectorsold by Lincoln Medical Ltd. of the United Kingdom and the EPIPEN®injector sold by Mylan Inc. of Pennsylvania.

Many injectors use powerful springs to drive a plunger rod into apre-filled syringe and inject the medicament into the tissue whilepushing the injector into the side of the leg or other body location.Some of these injectors have the advantage of visually shielding theneedle before and/or after use, thereby benefiting patients who have afear of needles. Present injectors can contain more than twenty-sixparts, including electronics and even speakers, and may be complicatedto assemble due to the amount and complexity of the parts, whichcontributes to high prices for the user. The additional parts alsoincrease the chance of failure of these complex devices.

SUMMARY

In one or more embodiments, an injector includes an outer tubular sleevedefining a longitudinal axis. In one or more embodiments, the injectorincludes a cam disposed within the outer sleeve. In one or moreembodiments, the injector includes an inner sleeve disposed partiallywithin the outer sleeve and a first end of the inner sleeve isconfigured to engage with the cam. In one or more embodiments, theinjector includes a syringe comprising a barrel, a needle mounted to anend of the barrel, a plunger, and a seal slidably mounted in the barrel.In some embodiments, the plunger is engaged with the outer sleeve in afixed spatial relationship such that the plunger and outer sleevetranslate as a unit throughout operation of the injector. In someembodiments, the outer sleeve is disposed and configured for axialtranslation relative to the inner sleeve from a first configuration. Insome embodiments, the inner sleeve is configured to extend from theouter sleeve a first distance to a second configuration in which theinner sleeve extends from the outer sleeve a second distance that isless than the first distance. In some embodiments, the inner sleeve isfurther configured to extend from the outer sleeve a to a thirdconfiguration in which the inner sleeve extends from the outer sleeve athird distance that is greater than the second distance and the camrotates from a first position to a second position thereby restrictingthe inner sleeve from axially translating with respect to the outersleeve.

In one or more embodiments, a medicament delivery system includes aninjector. In some embodiments, the injector includes an outer tubularsleeve defining a longitudinal axis. In some embodiments, the injectorincludes a cam disposed within the outer sleeve. In some embodiments,the injector includes an inner sleeve disposed partially within theouter sleeve and a first end of the inner sleeve is configured to engagewith the cam. In some embodiments, the injector includes a syringecomprising a barrel, a needle mounted to an end of the barrel, aplunger, and a seal slidably mounted in the barrel. In some embodiments,the plunger is engaged with the outer sleeve in a fixed spatialrelationship such that the plunger and outer sleeve translate as a unitthroughout operation of the injector. In some embodiments, the outersleeve is disposed and configured for axial translation relative to theinner sleeve from a first configuration. In some embodiments, the innersleeve is configured to extend from the outer sleeve a first distance toa second configuration in which the inner sleeve extends from the outersleeve a second distance that is less than the first distance. In someembodiments, the inner sleeve is further configured to extend from theouter sleeve a to a third configuration in which the inner sleeveextends from the outer sleeve a third distance that is greater than thesecond distance and the cam rotates from a first position to a secondposition thereby restricting the inner sleeve from axially translatingwith respect to the outer sleeve. In one or more embodiments, themedicament delivery system includes an adapter configured to couple to asecond end of the inner sleeve.

A variety of additional aspects will be set forth in the descriptionthat follows. The aspects can relate to individual features and tocombination of features. It is to be understood that both the foregoinggeneral description and the following detailed description are exemplaryand explanatory only and are not restrictive of the broad inventiveconcepts upon which the embodiments disclosed herein are based.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the devices and methods provided herein will be morefully disclosed in, or rendered obvious by, the following detaileddescription of the preferred embodiment of the invention, which is to beconsidered together with the accompanying drawings wherein like numbersrefer to like parts.

FIG. 1 is a side view of an injector according to one embodimentdescribed herein.

FIG. 2 is a side cross-sectional view of the injector of FIG. 1.

FIG. 3 is an exploded side view of the injector of FIG. 1.

FIG. 4 is an exploded side view of the outer sleeve, inner sleeve, andcam of the injector of FIG. 1.

FIG. 5A is a perspective view of the cam of the injector of FIG. 1.

FIG. 5B is an end view of the cam of FIG. 5A.

FIG. 6 is a perspective view of the inner sleeve of the injector of FIG.1.

FIG. 7 is a detail perspective view of an end of the inner sleeve ofFIG. 6.

FIG. 8 is a cross-sectional perspective view of the inner sleeve of FIG.6.

FIG. 9 is an end view of the inner sleeve of FIG. 6.

FIG. 10 is a perspective view of the outer sleeve of the injector ofFIG. 1.

FIG. 11 is a cross-sectional perspective view of the outer sleeve ofFIG. 10.

FIGS. 12A and 12B are side and side cross-sectional views, respectively,of the injector of FIG. 1 after removal of the cap.

FIGS. 13A and 13B are side and side cross-sectional views, respectively,of the injector of FIG. 1 after extending the needle of syringe from theinner sleeve of the injector to insert the needle in a target site.

FIGS. 14A and 14B are side and side cross-sectional views, respectively,of the injector of FIG. 1 after delivery of the medicament.

FIGS. 15A and 15B are side and side cross-sectional views, respectively,of the injector of FIG. 1 after the inner sleeve extends over the needleof the syringe.

FIG. 16A is an end view of the outer sleeve, inner sleeve, and cam ofthe injector of FIG. 1 prior to injection of medicament.

FIG. 16B is an end view of the outer sleeve, inner sleeve, and cam ofthe injector of FIG. 1 after completion of injection of the medicament.

FIG. 16C is an end view of the outer sleeve, inner sleeve, and cam ofthe injector of FIG. 1 after extension and lockout of the inner sleeve.

FIG. 17A is a cross-sectional perspective view of the outer sleeve,inner sleeve, and cam of the injector of FIG. 1 prior to injection ofmedicament.

FIG. 17B is a cross-sectional perspective view of the outer sleeve,inner sleeve, and cam of the injector of FIG. 1 after completion ofinjection of the medicament.

FIG. 17C is a cross-sectional perspective view of the outer sleeve,inner sleeve, and cam of the injector of FIG. 1 after extension andlockout of the inner sleeve.

FIG. 18A is a perspective view of the cap of the injector of FIG. 1.

FIG. 18B is a side cross-sectional view of the cap of FIG. 18A.

FIG. 19 is a perspective view of the needle cover engagement member ofthe injector of FIG. 1.

FIG. 20 is a perspective view of the plunger of the injector of FIG. 1.

FIG. 21 is a perspective view of an alternative embodiment of theplunger of the injector of FIG. 1.

FIG. 22 is a perspective view of a Luer adapter configured for use withthe injector of FIG. 1, according to one embodiment described herein.

FIG. 23 is a side cross-sectional view of the Luer adapter of FIG. 22.

FIG. 24 is a detail side cross sectional view of the tip of the Lueradapter of FIG. 22.

FIG. 25 is a detail cross-sectional perspective view of the Luer adapterof FIG. 22 attached to the injector of FIG. 1.

FIG. 26 is a detail cross-sectional perspective view of the Luer adapterof FIG. 22 attached to the adapter of FIG. 1 after extension of theneedle of the syringe.

FIG. 27 is a perspective view of a nasal spray adapter configured foruse with the injector of FIG. 1, according to one embodiment describedherein.

FIG. 28 is a side cross-sectional view of the nasal spray adapter ofFIG. 27.

FIG. 29 is a detail side cross sectional view of the tip of the nasalspray adapter of FIG. 27.

FIG. 30 is a detail side cross-sectional view of the nasal spray adapterof FIG. 27 attached to the injector of FIG. 1.

FIG. 31 is a side view of the syringe of the injector of FIG. 1.

FIG. 32 is a side cross-sectional view of the syringe of FIG. 31.

FIG. 33 is a cross-sectional perspective view of the outer sleeve andthe inner sleeve of the adapter of FIG. 1.

FIG. 34 is a perspective view of cam and the inner sleeve of theinjector of FIG. 1 showing the engagement of the cam elements of the camwith the cam teeth of the inner sleeve.

FIG. 35 is an exploded view of an atomizing insert of the nasal sprayadapter of FIG. 27.

FIG. 36 is a perspective view of the inner member of the atomizinginsert of FIG. 35.

FIG. 37 is a perspective view of an alternative embodiment of the innersleeve of the injector of FIG. 1.

FIG. 38 is a perspective view of an alternative embodiment of theplunger of the injector of FIG. 1.

FIG. 39 is a side view of the plunger of the injector of FIG. 38.

DETAILED DESCRIPTION

This description of preferred embodiments is intended to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description of this invention. The drawingfigures are not necessarily to scale and certain features of theinvention may be shown exaggerated in scale or in somewhat schematicform in the interest of clarity and conciseness. In the description,relative terms such as “horizontal,” “vertical,” “up,” “down,” “top,”and “bottom” as well as derivatives thereof (e.g., “horizontally,”“downwardly,” “upwardly,” etc.) should be construed to refer to theorientation as then described or as shown in the drawing figure underdiscussion. These relative terms are for convenience of description andnormally are not intended to require a particular orientation. Termsincluding “inwardly” versus “outwardly,” “longitudinal” versus “lateral”and the like are to be interpreted relative to one another or relativeto an axis of elongation, or an axis or center of rotation, asappropriate. Terms concerning attachments, coupling and the like, suchas “connected” and “interconnected,” refer to a relationship whereinstructures are secured or attached to one another either directly orindirectly through intervening structures, as well as both movable orrigid attachments or relationships, unless expressly describedotherwise. The term “operatively or operably connected” is such anattachment, coupling or connection that allows the pertinent structuresto operate as intended by virtue of that relationship. In the claims,means-plus-function clauses, if used, are intended to cover thestructures described, suggested, or rendered obvious by the writtendescription or drawings for performing the recited function, includingnot only structural equivalents but also equivalent structures. Theterms “medicament” or “drug” as used herein refers to any substance fordelivery to a target. For example, these terms include anticoagulants,vaccines, biologics, and any injectable fluid.

The present disclosure describes an injector for injecting medicamentinto a target site. The injector provides for easy use by a medicalprofessional, caregiver, or self-administration by patient and isconfigured for reliable use after being stored for long periods of time.In addition, because the injector utilizes a low number of parts, it isinexpensive and easy to manufacture. The injectors described herein canbe used to deliver, for example, epinephrine, ketamine, atropine,diazepam, or naloxone.

FIG. 1 shows a side view of an injector 100 according to one embodiment,and FIG. 2 shows a side cross-sectional view of the injector 100. FIG. 3shows an exploded view of the injector 100. The injector 100 includes aplunger 102, a biasing member 104, a syringe 106, a cam 108, an innersleeve 110, an outer sleeve 112, a needle cover engagement member 114,and a cap 116. As shown in FIG. 2, the syringe 106 is disposed in achamber defined by the inner sleeve 110, the outer sleeve 112, and thecap 116. As described in further detail herein, when a user desires toinject the medicament contained in the syringe 106, the user removes thecap 116 and selectively deploys the needle of the syringe 106 to injectthe medicament.

FIG. 4 shows an exploded view of the cam 108, the inner sleeve 110, andthe outer sleeve 112. As described in further detail herein, the cam108, the inner sleeve 110, and the outer sleeve 112 work together to:(i) cover the needle of the syringe prior to insertion of the needle inthe injection site; (ii) provide audible (e.g., a “click”) and/ortactile feedback upon completion of injection of the medicament; and(iii) cover the needle of the syringe after completion of injection toprevent inadvertent needle stick injuries.

As shown in FIG. 2, the cam 108 is disposed within the outer sleeve 112and is configured for axial translation within the outer sleeve 112. Asdescribed in more detail herein, the cam 108 is also configured torotate within the outer sleeve 112 during use of the injector 100. FIG.5A shows a perspective view of the cam 108 and FIG. 5B shows an end viewof the cam 108. The cam 108 includes a cylindrical body 120 and a ring122 extending from the cylindrical body 120 and having a larger outerdiameter than the cylindrical body 120—for example, at one end of thecylindrical body 120. The cam 108 further includes a plurality ofprotrusions 124 extending radially outward from the ring 122. Theprotrusions 124 are circumferentially spaced around the ring 122. Theprotrusions 124 are configured to guide translation and rotation of thecam 108 within the outer sleeve 112 during use, as described herein. Thecam 108 further includes cam elements 126 extending from the outside ofthe cylindrical body 120—for example, adjacent to the ring 122. The camelements 126 each include a cam face 128. The cam faces 128 are angledrelative to the circumference of the cylindrical body 120 such thatengagement with corresponding faces on the inner sleeve 110 imparts acircumferential force on the cam 108 that causes the cam 108 to rotateat desired times during operation of the injector 100, as described indetail herein. The cylindrical body 120 defines an aperture 130 to allowfor the passage of the plunger 102.

FIG. 6 shows a perspective view of the inner sleeve 110, and FIG. 37shows a perspective view of an alternative inner sleeve 110. FIG. 7shows a detailed perspective view of an end of the inner sleeve 110.FIG. 8 shows a cross-sectional perspective view of the inner sleeve 110.FIG. 9 shows an end view of the inner sleeve 110. The inner sleeve 110includes a cylindrical body 134 extending from a first end 136 to asecond end 138. The inner sleeve 110 further includes a ring 140extending from the cylindrical body 134 and having a larger outerdiameter than the cylindrical body 134 and a plurality of projections142 extending radially outward from the ring 140—for example, at thefirst end 136 of the cylindrical body 134. As described in furtherdetail herein, the projections 142 are configured to restrict rotationof the inner sleeve 110 in the outer sleeve 112 during operation of theinjector 100. The inner sleeve 110 further includes a plurality of camteeth 144 extending from the first end 136 of the cylindrical body 134.The cam teeth 144 each include an angled face 146 (i.e., angled relativeto the circumference of the cylindrical body 134) configured to engage acam face 128 of the cam elements 126 of the cam 108 during operation ofthe injector 100 to cause rotation of the cam 108, as described indetail herein. As shown in FIGS. 8 and 9, the inner sleeve 110 furtherincludes a plurality of ribs 148 extending radially inward from thecylindrical body 134 and extending longitudinally along the cylindricalbody 134. The ribs 148 locate and retain the syringe 106 in positionwhen it is disposed within the cylindrical body 134 of the inner sleeve110. The inner sleeve 110 further includes a window 150 extendingthrough the inner sleeve 110 that allows a user to view the contents ofthe syringe 106 before injection (e.g., after removal of the cap 116).It is noted that the inner sleeve 110 illustrated in FIG. 37 includesone or more of the same or similar features as the inner sleeve 110illustrated in FIG. 6, and the inner sleeve 110 of FIG. 37 is providedto show that inner sleeve 110 may include any number of cam teeth 144,such as six cam teeth, to correspond to the number of cam elements 126of cam 108.

The inner sleeve 110 further includes ridges 152 extending from thecylindrical body 134 at the second end 138 of the cylindrical body 134.The ridges 152 each extend partially around the circumference of theinner sleeve 110 and include faces that are disposed at an acute anglewith respect to a circumference of the cylindrical body 134. Asdescribed in further detail herein, the ridges 152 allow for theconnection of adapters to the injector 100 by engaging with threads ofthe adapters.

The inner sleeve 110 further includes a rib 154 extending from a frontface 156 of the inner sleeve 110 and extending circumferentially aroundan aperture 158 through the front face 156. The aperture 158 isconfigured to allow the passage of the needle of the syringe 106therethrough during operation of the injector. As described in furtherdetail herein, the rib 154 is configured to engage a diaphragm of anadapter coupled to the injector 100 to seal the inner sleeve 110 to theadapter.

FIG. 10 shows a perspective view of the outer sleeve 112, and FIG. 11shows a cross-sectional perspective view of the outer sleeve 112. Theouter sleeve 112 includes a cylindrical body 160 for housing the innersleeve 110, the cam 108, and the syringe 106. The cylindrical body 160extends from a first end 162 to a second end 164. The outer sleeve 112includes a plurality of first ribs 166 and a plurality of second ribs168 each extending inward from the cylindrical body 160. The first ribs166 extend from the second end 164 and toward the first end 162,however, the first ribs 166 do not extend all the way to the first end162. As described further herein, this allows the cam 108 to rotatewithin the outer sleeve 112 at a specific stage of operation of theinjector 100, specifically at completion of injection of the medicament.The second ribs 168 are spaced apart from the second end 164. Asdescribed in further detail herein, this allows the cam 108 to rotatewithin the outer sleeve 112 at a specific stage of operation of theinjector 100, specifically after removal of the injector 100 from theinjection site and extension of the inner sleeve 110. In variousembodiments, the first 166 and second 168 ribs extend parallel to thelongitudinal axis A of the injector 100 (shown in FIG. 3). The firstribs 166 define a shoulder 170 configured to engage the ring 140 on theinner sleeve 110, when the inner sleeve 110 is extended, to locate theinner sleeve 110.

The outer sleeve 112 further includes fingers 172 extending from thesecond end 164 of the cylindrical body 160. A groove 174 is defined inthe outside of the fingers 172. The groove 174 is configured to receivea bead on the cap 116 to couple the cap 116 to the outer sleeve 112, asdescribed in more detail herein. The outer sleeve 112 also includesramped projections 176 configured to engage the cap 116 when the cap 116is in place on the injector 100. The ramped projections 176 may extendoutward from the cylindrical body 160 and along the outside of one ormore of the fingers 172. The ramped projections 176 may have surfacesthat are inclined relative to the longitudinal axis of the outer sleeve112. As described in more detail herein, the inclined faces cause thecap 116 to be pushed outward, away from the first end 162 of the outersleeve 112 when the cap 116 is twisted relative to the outer sleeve 112.The fingers 172 can flex inward (toward the longitudinal axis A) duringinstallation and removal of the cap 116.

The outer sleeve 112 has apertures 178 at the first end 162 configuredto receive teeth of the plunger 102 to couple the plunger 102 to theouter sleeve 112, as described herein. The outer sleeve 112 also hasramps 180 at the first end 162 to provide a lead in for the teeth of theplunger 102.

FIGS. 18A and 18B show perspective and cross-sectional side views,respectively, of the cap 116. The cap 116 can include features thatallow a user to grasp the cap 116 and remove it from the injector 100.The cap 116 includes a bead 182 extending circumferentially around theinside of the cap 116 to engage the groove 174 in the outer sleeve 112.The cap 116 defines recesses 184 extending into the end of the cap 116and configured to receive the ramped projections 176 of the outer sleeve112. When the cap is twisted by a user, the sides of the recesses 184contact the ramped projections 176. This contact imparts an axial forceon the cap 116 that pushes the cap 116 axially, way from the outersleeve 112 to assist the user in removing the cap 116 from the injector100. The cap 116 has a boss 186 at its bottom end. The boss 186 includesa groove 187 that is configured to receive a portion of the needle coverengagement member 114.

As shown in FIG. 19, the needle cover engagement member 114 includes acylindrical body 188 and teeth 190 extending inward from the cylindricalbody 188. The teeth 190 are configured to engage the needle cover of thesyringe 106. The teeth 190 can be formed by pressing portions of thecylindrical body 188 inward, toward the center of the cylindrical body188. The needle cover engagement member 114 further includes feet 192 toengage the cap 116 to couple the needle cover engagement member 114 tothe cap 116. Specifically, the feet 192 engage the groove 187 in the cap116. Hence, the removal of the cap 116 also removes the needle coverfrom the syringe 106.

FIG. 31 shows a side view of the syringe 106 and FIG. 32 shows a sidecross-sectional view of the syringe 106. The syringe 106 may bepre-filled with a medicament and includes a barrel 194, a needle 196, aneedle cover 198, and a plunger seal 200. The barrel 194 can be a glassbarrel, such as those constructed from straight cane glass.Alternatively, the barrel 194 can be constructed of a polymericmaterial. The barrel 194 can be coated with a material to reducechemical interactions between the barrel 194 and the medicament. Theneedle 196 is mounted at the distal end of the barrel 194 and defines alumen through which medicament can be delivered from the barrel 194 tothe target site. The needle 196 can be attached to the barrel 194 usingany appropriate method, such as staking and adhesives. The plunger seal200 is disposed within the barrel 194 and is configured for axialtranslation within the barrel 194. The plunger seal 200 can beconstructed of an elastomeric material and provide a seal against theinner wall of the barrel 194 to maintain the sterility of the medicamentprior to use.

FIG. 20 shows a perspective view of the plunger 102. The plunger 102includes a cap portion 202 and a plunger rod 204 extending from the capportion 202. The plunger rod 204 can include a threaded portion 205 atthe end opposite the cap portion 202 for engaging the plunger seal 200of the syringe 106. During assembly of the injector 100, the plunger rod204 is inserted through aperture 130 in the cam 108 and through theaperture 158 in the inner sleeve 110 so that the plunger rod 204 canengage the plunger seal 200 of the syringe 106. The plunger 102 canfurther include one or more arms 206 extending from the cap portion 202for engaging the apertures 178 in the outer sleeve 112 to lock theplunger 102 to the outer sleeve 112, as shown in FIG. 2, for example.Each arm 206 can include an outwardly extending tooth 208 for engagingthe aperture 178. During assembly, each tooth 208 contacts a respectiveone of the ramps 180 on the outer sleeve 112 and the arm 206 flexesradially inward. When the tooth 208 reaches the aperture 178 the arm 206flexes back toward its natural position such that the tooth 208 engagesthe aperture 178. With the teeth 208 engaged with the apertures 178, theplunger 102 is locked to the outer sleeve 112 such that they translatetogether during use, as described herein. As illustrated, for example,in FIGS. 20 and 21, the plunger 102 can further include a clip 210extending from the cap portion 202 that can be used to clip the injector100 to a belt or other item for ease of transportation and retrieval ofthe injector 100. In another example, as illustrated in FIGS. 38 and 39,the plunger 102 can alternatively include an alligator clip 211 that canbe used to clip the injector 100 to a belt or other item for ease oftransportation and retrieval of the injector 100. In some cases, thealligator clip 211 may be molded into a portion of the injector 100. Forexample, an end 213 of the alligator clip 211 may be molded into theouter sleeve 112 of the injector, thereby securing the alligator clip211 to the injector 100. In some other cases, the alligator clip 211 maybe removably coupled to the injector 100. For example, the end 213 ofthe alligator clip 211 may include a ring-like structure that whenplaced on the outer sleeve 112 expands over the outer sleeve 112 andsnaps around the surface of the outer sleeve 112 to fasten to theinjector 100. In such cases, the alligator clip 211 may be a separatecomponent from the plunger 102.

In some embodiments, as shown in FIG. 21, the cap 116 of the plunger 102includes an indicator 212 that corresponds to the type of medicamentcontained in the syringe 106. For example, the indicator 212 can be inthe shape of a circle, an oval, a hexagon, a trapezoid, a heart, a star,or any other appropriate or desired shape.

The biasing member 104 can be, for example, a helical coil spring.However, it should be understood that the biasing member 104 can take onother forms. For example, the biasing member 104 can be a compressible,elastomeric component.

The operation of the injector 100 will now be described. FIGS. 1 and 2show side and side cross-sectional views, respectively, of the injector100 in an initial configuration, which may be the configuration in whichthe injector 100 is provided to users. In this initial configuration,the cap 116 is in place on the injector 100 and is coupled to the outersleeve 112. Specifically, the ramped projections 176 on the outer sleeve112 are disposed in the recesses 184 on the cap 116 and the bead 182 onthe cap 116 is disposed in the groove 174 in the outer sleeve 112. Inaddition, the teeth 190 of the needle cover engagement member 114 areengaged with the needle cover 198 of the syringe 106. When the user isready to use the injector 100, the user can twist and/or pull the cap116 with respect to the outer sleeve 112 to remove the cap 116 from theinjector 100. Removal of the cap 116 also removes the needle cover 198due to the engagement of the teeth 190 with the needle cover 198.

FIGS. 12A and 12B show side and side cross-sectional views,respectively, of the injector 100 after removal of the cap 116. As canbe seen in these figures, the inner sleeve 110 is extended, as a resultof the force applied by the biasing member 104, such that the innersleeve 110 shields the needle 196 of the syringe 106. As shown in FIG.12B, the biasing member 104 is positioned such that one end of thebiasing member 104 is in contact with the cap portion 202 of the plunger102 and the opposite end of the biasing member 104 is in contact withthe cam 108. With the injector 100 in the configuration shown in FIGS.12A and 12B, the biasing member 104 may be fully extended or nearlyfully extended. As a result, the biasing member 104 is not imparting alarge force on the inner sleeve 110 or the other components of theinjector 100. This allows the injector 100 to be stored for longdurations without fear that components will be damaged or becomepermanently deformed as a result of being exposed to high forces duringstorage. This may provide an advantage over prior art devices thatinclude springs or other biasing members that are in a compressed orloaded state during storage. The ring 140 of the inner sleeve 110 is incontact with the shoulder 170 of the outer sleeve 112 to prevent theinner sleeve 110 from falling out of the outer sleeve 112.

FIG. 16A shows an end view of the outer sleeve 112, the inner sleeve110, and the cam 108 when the injector 100 is in the configuration shownin FIGS. 12A and 12B, and FIG. 17A shows a cross-sectional perspectiveview of the same components in this configuration. The other componentsof the injector 100 are not shown for illustrative purposes. As shown inFIG. 34, the cam teeth 144 of the inner sleeve 110 are in contact withthe cam elements 126 of the cam 108. Any appropriate number of cam teeth144 and cam elements 126 can be used. For example, in one embodiment,the inner sleeve 110 includes seven cam teeth 144 (as shown in, forexample, FIG. 7) and the cam 108 includes seven cam elements 126 (asshown in, for example, FIG. 5A). In another example, in anotherembodiment, the inner sleeve 110 includes six cam teeth 144 (as shownin, for example, FIG. 37) and the cam 108 includes six cam elements 126that correspond to the six cam teeth 144. The angle that the interfacingsurfaces (cam faces 128 and angled faces 146) make with the longitudinalaxis A can be chosen to provide the desired circumferential force on thecam 108. For example, in one embodiment, these interfacing surfaces eachdefine a helix angle of about 30 degrees with respect to thelongitudinal axis A.

As shown in FIG. 33, the projections 142 of the inner sleeve 110 aredisposed on opposite sides of respective first ribs 166 of the outersleeve 112, with this engagement preventing rotation of the inner sleeve110 with respect to the outer sleeve 112 during use of the injector 100.For example, projections 142-1 and 142-2 are positioned on oppositesides of first rib 166-1. Each protrusion 124 of the cam 108 ispositioned between a first rib 166 and a second rib 168 of the outersleeve 112. For example, as shown in FIGS. 16A and 17A, the protrusion124-1 is positioned between first rib 166-1 and second rib 168-1. Theinner sleeve 110 can include more projections 142 than the cam 108 hasprotrusions 124. As a result, the inner sleeve 110 can include aprojection 142 on each side of each first rib 166 while the cam 108 hasa protrusion 124 on only a single side of each first rib 166.

When the user wishes to inject the medicament contained in the syringe106, the user brings the second end 138 of the inner sleeve 110 intocontact with the injection site (i.e., the patient's tissue). With theinner sleeve 110 in contact with the injection site, applying pressureon the plunger 102 causes the outer sleeve 112 to translate toward theinjection site and over the inner sleeve 110, thereby compressing thebiasing member 104. As the outer sleeve 112 travels forward, theprojections 142 of the inner sleeve 110 and the protrusions 124 of thecam 108 slide along the first ribs 166 and the second ribs 168.

As the plunger 102 and the outer sleeve 112 translate forward, thesyringe 106 is also moved forward as a result of the pressure applied bythe plunger 102 on the plunger seal 200. The forward movement of thesyringe 106 causes the needle 196 to extend through the aperture 158 atthe end of the inner sleeve 110, as shown in FIGS. 13A and 13B, and beinserted into the injection site (i.e., the patient's tissue). Thebiasing member 104 is not shown in FIGS. 13 and 14 for clarity, but itshould be understood that the biasing member 104 would be present andcompressed in these configurations. The syringe 106 moves forward untilthe flange 194 a at the end of the barrel 194 contacts the end of theribs 148 in the inner sleeve 110. With the flange 194 a in contact withthe ribs 148, further translation of the syringe barrel 194 with respectto the inner sleeve 110 is prevented and continued depression of theplunger 102 causes translation of the plunger seal 200 within the barrel194 and injection of the medicament stored within the barrel 194. Thisposition is shown in FIGS. 14A and 14B. The length of the ribs 148(i.e., the distance from the end of the ribs 148 to the front face ofthe inner sleeve 110) can be chosen to provide the desired insertiondepth of the needle 196. Because the contact of the flange 194 a of thesyringe barrel 194 with the ribs 148 controls the extent of the needle196 that extends from the inner sleeve 110, changing the length of theribs 148 may change the depth of insertion. Changing the length of theribs 148 may also be used to customize the injector 100 for use withdifferent syringes 106 or needles 196. This controlled depth ofinsertion provides advantages in controlling the depth of insertion toensure the medicament is injected in the proper location (e.g.,intramuscular injections).

When the end of the injection is reached (i.e., when the desired amountof medicament in the syringe 106 has been injected), the protrusions 124of the cam 108 reach the end of the first ribs 166. Once the protrusions124 clear the first ribs 166, the contact of the cam faces 128 of thecam elements 126 and the angled faces 146 of the projections 142 on theinner sleeve 110 causes the cam 108 to rotate. As can be seen bycomparing the position of protrusion 124-1 in FIGS. 16A and 16B and inFIGS. 17A and 17B, the cam 108 has rotated counterclockwise. Rotation ofthe cam 108 causes each protrusion 124 to contact a respective one ofthe second ribs 168 (e.g., protrusion 124-1 contacts second rib 168-2).This contact can provide audible (e.g., a “click”) and/or tactilefeedback to the user that injection is complete (e.g., a clickingsound). The length of the first ribs 166 can be chosen to achieve thedesired stroke of the plunger rod 205—and, thereby, the plunger seal200—within the syringe barrel 194. This ensures the proper amount ofmedicament is delivered prior to the audible or tactile indication thatdelivery is complete. The length of the first ribs 166 can be customizedbased on the length of the syringe barrel 194. This may allow theinjector 100 to be configured for different syringe sizes withoutmodifying each of the components of the injector 100. For example, theplunger 102, the cam 108, the inner sleeve 110, and the cap 116 can beused with an outer sleeve 112 that has first ribs 166 customized to fita particular syringe. This may reduce tooling costs and simplify andreduce the amount of inventory that a manufacturer must carry.

After completion of the injection, the user can begin to remove theinjector 100 from the injection site. As the user does so, the innersleeve 110 and cam 108, under the urging of the biasing member 104,travel back toward the second end 164 of the outer sleeve 112 to theposition shown in FIGS. 15A and 15B. When the protrusions 124 of the cam108 reach the end of the second ribs 168, the contact of the cam faces128 of the cam elements 126 and the angled faces 146 of the cam teeth144 again causes rotation of the cam 108. In this case, the cam 108rotates such that the cam elements 126 move toward, and may come incontact with, the vertical faces 147 (shown in FIG. 7) of the cam teeth144. When the cam 108 comes to a stop, each protrusion 124 of the cam108 is aligned and in contact with the end of a respective one of thesecond ribs 168. For example, as shown in FIGS. 16C and 17C, protrusion124-1 is aligned with and in contact with the end of second rib 168-2.In this position, the cam 108 and inner sleeve 110 cannot translateaxially within the outer sleeve 112. Thus, the inner sleeve 110 and theouter sleeve 112 are locked in their positions. As a result, the innersleeve 110 cannot be retracted and the needle 196 cannot again beexposed from the end of the inner sleeve 110. This prevents inadvertentneedle stick injuries that can occur with prior art injectors.

In another aspect, as shown in FIGS. 22-26, a Luer adapter 300 to beused with the injector 100 is provided. The Luer adapter 300 allows themedicament in the syringe 106 to be provided to a patient via, forexample, an intravenous line. The Luer adapter 300 includes a body 302having a cylindrical portion 304 and a tip 306 at one end of thecylindrical portion 304. The cylindrical portion 304 defines a cavity308 that is open at the end of the cylindrical body 302 that is oppositethe tip 306. The cavity 308 is configured to at least partially receivethe injector 100. The adapter 300 includes an interior wall 310 definingthreads to engage the ridges 152 at the end of the inner sleeve 110 tocouple the adapter 300 to the inner sleeve—for example, by way of a ¼turn thread engagement.

At the end of the tip 306, the adapter 300 includes a Luer connector314. The Luer connector 314 can be a male Luer connector for connectionto a female Luer fitment of a tubing set. Alternatively, the Luerconnector 314 can be a female Luer connector for connection to a maleLuer fitment. The connection of the adapter 300 with the tubing set may,for example, use locking or slipping type Luer connections, such asthose sold under the names LUER-LOK™ and LUER-SLIP™ by Becton Dickinson.

The adapter further includes a diaphragm 316 positioned within the tip306. The diaphragm 316 includes a frustoconical portion 318 and a flange320. The flange 320 is configured to be positioned between a shoulder ofthe adapter 300 and the inner sleeve 110. The diaphragm 316 can besealed by ribs on the inner sleeve (e.g., rib 154) and the shoulder ofthe adapter 300. During use, the frustoconical portion 318 of thediaphragm 316 is pierced by the needle 196 of the syringe 106. Thediaphragm 316 can be constructed from, for example, an elastomericmaterial. The diaphragm 316 is configured to ensure that the medicamentis delivered though the Luer connector 314 and does not leak from theinjector 100 or the Luer adapter 300.

The connector 314 and the diaphragm 316 together define a channel 322within which the needle 196 is at least partially disposed while themedicament is injected, as shown in FIG. 26.

The adapter 300 can further include finger flanges 324 extending outwardfrom the cylindrical portion 304. To deliver the medicament from thesyringe 106, the user can grasp the injector 100 with the user's fingersaround the finger flanges 324 and with the cap portion 202 of theplunger 102 resting against the user's palm. The user can then squeezeto cause dispensing of the medicament. After dispensing the medicament,the user can release to allow the inner sleeve 110 to slide outward withrespect to the inner sleeve 110, as described above, such that theneedle 196 is retracted from the diaphragm 316. With the position of theinner sleeve 110 locked, the user can then remove the adapter 300 fromthe injector 100 and dispose of both the injector 100 and the Lueradapter 300.

FIG. 25 shows the adapter 300 coupled to the injector 100. As shown, thesecond end 138 of the inner sleeve 110 is engaged with the diaphragm 316and the needle 196 is disposed in the inner sleeve 110. FIG. 26 showsthe injector 100 and the adapter 300 after depression of the plunger 102and the outer sleeve 112 to extend the needle 196 and pierce thefrustoconical portion 318 of the diaphragm 316 such that it is disposedin the channel 322. With the needle 196 in this position, depression ofthe plunger 102 causes the medicament to be dispensed through tubingcoupled to the Luer connector 314.

In another embodiment, a nasal spray adapter 400 is provided for usewith the injector 100. The nasal spray adapter 400 allows the medicamentin the syringe 106 to be provided to a patient via nasal delivery. Thenasal spray adapter 400 includes a body 402 having a cylindrical portion404 and a tip 406 at one end of the cylindrical portion 404. Thecylindrical portion 404 defines a cavity 408 configured to partiallyreceive the injector 100. The adapter 400 includes an interior wall 410defining threads to engage the ridges 152 at the end of the inner sleeve110 to couple the adapter 400 to the inner sleeve—for example, by way ofa ¼ turn thread engagement.

At the end of the tip 406, the adapter 400 includes an aperture 412 toallow medicament to be expelled into a user's nasal passages via aspray. The adapter 400 further includes a diaphragm 416 positionedwithin the tip 406. The diaphragm 416 includes a frustoconical portion418 and a flange 420. The flange 420 is configured to be positionedbetween a shoulder of the adapter 400 and the second end 138 of theinner sleeve 110. The diaphragm 416 can be sealed by ribs on the innersleeve 110 (e.g., rib 154) and the adapter 400. During use, thefrustoconical portion 418 of the diaphragm 416 is pierced by the needle196 of the syringe 106, as shown in FIG. 30, so that the medicament canbe expelled through the aperture 412. The diaphragm 416 can beconstructed from, for example, an elastomeric material. The diaphragm416 is configured to ensure that the medicament is delivered though theaperture 412 and does not leak from the injector 100 or the adapter 400.

Further, as shown in FIG. 28 an atomizing insert 414 can be positionedin the tip 406 adjacent to the aperture 412. The atomizing insert 414may convert the medicament into fine particles or droplets for deliveryto the patient via the aperture 412. The atomizing insert 414 is shownin more detail in the cross-sectional views of FIGS. 29 and 30 and inFIGS. 35 and 36. As shown in FIGS. 29 and 30, the atomizing insert 414is positioned in the tip 406 between the diaphragm 416 and the aperture412. FIG. 36 shows an exploded view of the atomizing insert 414. Theatomizing insert 414 may include an inner member 430 and an outer member432. The outer member 432 defines an inner passage 436 within which theinner member 430 is disposed. FIG. 36 shows a perspective view of theinner member 430. The inner member 430 may be substantially cylindricaland include one or more channels 438 extending longitudinally along thelength of the inner member 430. The channels 438 allow for the flow ofmedicament between the inner member 430 and the outer member 432 towardthe aperture 412. The inner member 430 may further include tracks 440formed in the distal face 442 of the inner member. Each track 440extends from a respective channel 438 toward a center of the innermember 430. The tracks 440 may meet at the center of the distal face 442adjacent to the aperture 412. The tracks 440 may follow curved pathssuch that they impart a swirling motion on the medicament travelingtoward the aperture 412.

The adapter 400 can further include finger flanges 424 extending outwardfrom the cylindrical portion 404. To deliver the medicament from thesyringe 106, the user can grasp the injector 100 with the user's fingersaround the finger flanges 424 and with the cap portion 202 of theplunger 102 resting against the user's palm. The user can then squeezeto cause dispensing of the medicament. After dispensing the medicament,the user can release to allow the inner sleeve 110 to slide outward withrespect to the inner sleeve 110, as described above, such that theneedle 196 is retracted from the diaphragm 416. With the position of theinner sleeve 110 locked, the user can then remove the adapter 400 fromthe injector 100 and dispose of both the injector 100 and the nasalspray adapter 400.

The nasal spray adapter 400 allows for the medicament to be deliveredintranasally, which avoids the need for an insertion of a needle intothe patient, which may be preferable for some patients, specifically,those with a fear of needles or those with missing limbs or who lackadequate peripheral circulation. By delivering the medicament across themucosal membrane, and to the patient's blood stream, the injector withnasal spray adapter 400 delivers an effective dose of delivery. This canbe particularly useful for medicaments used to treat opioid overdoses,such as Naloxone.

In various embodiments, a kit is provided. The kit includes the injector100, the Luer adapter 300, and the nasal spray adapter 400. By providingthe nasal spray adapter 400 and the Luer adapter 300, the medicament canbe delivered either via the spray nozzle to the mucosal membranes,intravenously using the Luer adapter 300, or via the needleintramuscularly, subcutaneously, intraosseously, or at any otherappropriate depth. This provides the user or patient with the option attime of delivery, allowing them to choose the method of delivery whichis more comfortable or most effective for them.

In another embodiment, a method of operating an injector is provided.The method includes removing a cap from the injector. The methodincludes placing an end of an inner sleeve against the target location.With the injector in place, a force is applied to an outer sleeve.Applying the force to the outer sleeve (i) causes axial translation ofthe outer sleeve and a syringe relative to the inner sleeve, (ii) causesa needle of a syringe to extend out from the distal end of the innersleeve and into the target location, and (iii) causes the flange on thesyringe barrel to contact a rib on the inner sleeve. Subsequently, acontinued force is applied to the outer sleeve and plunger. Applying thecontinued force to the outer sleeve causes translation of a plunger rodand a seal within the syringe to cause delivery of the medicament. Afterdelivery of the medicament, the injector is removed from the targetlocation. A biasing member applies a force on the inner sleeve to causethe inner sleeve to translate in the distal direction with respect tothe outer sleeve to cover the needle of the syringe such that the innersleeve is locked in place with respect to the outer sleeve.

In another embodiment, a method of using an injector and a nasal sprayadapter to deliver a medicament intranasally is provided. A cap of theinjector is first removed. The nasal spray adapter is engaged with theinjector. A tip of the nasal spray adapter is placed within or adjacentto a nostril of the patient. An outer sleeve of the injector istranslated toward the tip of the nasal spray adapter to expel themedicament through the tip of the nasal spray adapter and to thepatient.

In another embodiment, a method of using an injector to deliver amedicament intravenously is provided. A cap of the injector is firstremoved. A Luer adapter is connected to the injector. The Luer adapteris coupled to a tubing set. An outer sleeve of the injector istranslated toward the Luer fitment to deliver the medicament through theLuer connector, through the tubing set, and to the patient.

While the foregoing description and drawings represent preferred orexemplary embodiments of the present invention, it will be understoodthat various additions, modifications and substitutions may be madetherein without departing from the spirit and scope and range ofequivalents of the embodiments described herein. In particular, it willbe clear to those skilled in the art that the present invention may beembodied in other forms, structures, arrangements, proportions, sizes,and with other elements, materials, and components, without departingfrom the spirit or essential characteristics thereof. In addition,numerous variations in the methods/processes described herein may bemade without departing from the spirit of the invention. One skilled inthe art will further appreciate that the invention may be used with manymodifications of structure, arrangement, proportions, sizes, materials,and components and otherwise, used in the practice of the invention,which are particularly adapted to specific environments and operativerequirements without departing from the principles of the presentinvention.

What is claimed is:
 1. An injector comprising: an outer tubular sleevedefining a longitudinal axis; a cam disposed within the outer sleeve; aninner sleeve disposed partially within the outer sleeve and a first endof the inner sleeve is configured to engage with the cam; and a syringecomprising a barrel, a needle mounted to an end of the barrel, aplunger, and a seal slidably mounted in the barrel, the plunger beingengaged with the outer sleeve in a fixed spatial relationship such thatthe plunger and outer sleeve translate as a unit throughout operation ofthe injector, wherein the outer sleeve is disposed and configured foraxial translation relative to the inner sleeve from a firstconfiguration, wherein the inner sleeve is configured to extend from theouter sleeve a first distance to a second configuration in which theinner sleeve extends from the outer sleeve a second distance that isless than the first distance, and wherein the inner sleeve is furtherconfigured to extend from the outer sleeve a to a third configuration inwhich the inner sleeve extends from the outer sleeve a third distancethat is greater than the second distance and the cam rotates from afirst position to a second position thereby restricting the inner sleevefrom axially translating with respect to the outer sleeve.
 2. Theinjector of claim 1, further comprising a cap and the syringe furthercomprises needle cover, wherein the cap is configured to engage theneedle cover such that removal of the cap from the injector removes theneedle cover from the syringe.
 3. The injector of claim 1, wherein asecond end of the inner sleeve comprises a ridge extending from an outersurface of the inner sleeve, the ridge configured to engage with anadapter to secure the adapter to the injector.
 4. The injector of claim3, wherein a body of the adapter comprises a cavity sized to receive thesecond end of the inner sleeve, an interior wall of the cavity beingthreaded and configured to engage with the ridge of the second end. 5.The injector of claim 3, wherein the adapter comprises a luer adapter todeliver medicament intravenously or a nasal spray adapter to delivermedicament intranasally.
 6. The injector of claim 1, wherein: aninterior surface of the inner sleeve comprises a plurality of ribsextending radially inward and in a longitudinal direction of the innersleeve, and the plurality of ribs is configured to position and retainthe syringe within the inner sleeve.
 7. The injector of claim 1, furthercomprising a biasing member positioned between a surface of the cam anda lower surface of the plunger, the biasing member configured to axiallytranslate the outer sleeve relative to the inner sleeve.
 8. The injectorof claim 7, wherein the biasing member is configured in an unloadedstate in the first configuration.
 9. The injector of claim 1, wherein:the cam comprises a plurality of protrusions extending along a length ofthe cam and circumferentially spaced around the cam, and each of theplurality of protrusions having an angled face configured to engage witha corresponding angled face on the first end of the inner sleeve suchthat engagement of the angled faces imparts a circumferential force onthe cam causing the cam to rotate.
 10. The injector of claim 1, wherein:the cam comprises a cylindrical body and a ring disposed on an end ofthe cam; the ring having a larger diameter than the diameter of thecylindrical body, and a plurality of first protrusions circumferentiallyspaced around the ring and protruding radially outwards from the cam;and the cylindrical body having a plurality of second protrusionscircumferentially spaced around the cylindrical body, each of theplurality of second protrusions having an angled face configured toengage with a corresponding angled face on the first end of the innersleeve.
 11. The injector of claim 1, wherein: the cam comprises aplurality of first protrusions circumferentially spaced around the camand protruding radially outwards from the cam; and the first end of theinner sleeve comprises a plurality of second protrusionscircumferentially spaced around the inner sleeve and protruding radiallyoutwards from the first end;
 12. The injector of claim 11, wherein aninterior surface of the outer sleeve comprises a first set of ribscircumferentially spaced around the interior surface of the outer sleeveand extending a first length from a second end of the outer sleeve to afirst area spaced apart from a first end of the outer sleeve, and asecond set of ribs circumferentially spaced around the interior surfaceof the outer sleeve and extending a second length from the first end ofthe outer sleeve to a second area spaced apart from the second end ofthe outer sleeve.
 13. The injector of claim 12, wherein in the secondconfiguration two of the plurality of second protrusions of the innersleeve and two of the plurality of first protrusions of the cam are eachpositioned on opposite sides of a rib of the first set of ribs of theouter sleeve.
 14. The injector of claim 12, wherein in the thirdconfiguration two of the plurality of second protrusions of the innersleeve and two of the plurality of first protrusions of the cam are eachpositioned on opposite sides of a rib of the second set of ribs of theouter sleeve.
 15. The injector of claim 12, wherein: two of theplurality of second protrusions of the inner sleeve and two of theplurality of first protrusions of the cam are each positioned onopposite sides of a rib of the first set of ribs of the outer sleeve;and when the plurality of second protrusions translate beyond the end ofthe first set of ribs of the outer sleeve, the cam is configured torotate such that two of the plurality of second protrusions of the innersleeve and two of the plurality of first protrusions of the cam are eachpositioned on opposite sides of a rib of the second set of ribs of theouter sleeve.
 16. The injector of claim 15, wherein the needle isprevented from being exposed when two of the plurality of secondprotrusions of the inner sleeve and two of the plurality of firstprotrusions of the cam are each positioned on opposite sides of a rib ofthe second set of ribs of the outer sleeve.
 17. A medicament deliverysystem, comprising: an injector comprising: an outer tubular sleevedefining a longitudinal axis, a cam disposed within the outer sleeve, aninner sleeve disposed partially within the outer sleeve and a first endof the inner sleeve is configured to engage with the cam, and a syringecomprising a barrel, a needle mounted to an end of the barrel, aplunger, and a seal slidably mounted in the barrel, the plunger beingengaged with the outer sleeve in a fixed spatial relationship such thatthe plunger and outer sleeve translate as a unit throughout operation ofthe injector, wherein the outer sleeve is disposed and configured foraxial translation relative to the inner sleeve from a firstconfiguration, wherein the inner sleeve is configured to extend from theouter sleeve a first distance to a second configuration in which theinner sleeve extends from the outer sleeve a second distance that isless than the first distance, and wherein the inner sleeve is furtherconfigured to extend from the outer sleeve a to a third configuration inwhich the inner sleeve extends from the outer sleeve a third distancethat is greater than the second distance and the cam rotates from afirst position to a second position thereby restricting the inner sleevefrom axially translating with respect to the outer sleeve; and anadapter configured to couple to a second end of the inner sleeve. 18.The medicament delivery system of claim 17, wherein the adapter furthercomprises a cavity sized to receive a second end of the inner sleeve, aninterior wall of the cavity being threaded and configured to engage witha ridge on the second end, the ridge extending from an outer surface ofthe inner sleeve.
 19. The medicament delivery system of claim 17,wherein the adapter comprises a luer adapter to deliver medicamentintravenously or a nasal spray adapter to deliver medicamentintranasally.
 20. The medicament delivery system of claim 17, furthercomprising a biasing member positioned between a surface of the cam anda lower surface of the plunger, the biasing member configured to axiallytranslate the outer sleeve relative to the inner sleeve.